Principal Statistical Programmer

Ephicacy; United States; Remote; USD 100,000 - 150,000; Full time

Job summary

A leading company in the pharmaceutical manufacturing industry is seeking a Principal Statistical Programmer. This mid-senior level position requires expertise in SAS programming and experience with clinical trial data analysis, particularly in oncology. The successful candidate will develop complex models, lead regulatory submissions, and ensure compliance with FDA/EMA requirements. If you have a strong background in statistical programming and a passion for drug development, we invite you to apply.

Qualifications

• At least 10 years of SAS programming experience in the Pharmaceutical & Biotech industry.
• Experience with drug development life cycle and clinical trial data.
• Knowledge of relevant therapeutic areas and contributions in late-phase clinical trials.

Responsibilities

• Develop and resolve complex models and procedures using advanced professional knowledge.
• Lead programming for regulatory submissions and integrated summaries.
• Standardize and automate across studies or multiple oncology indications.

Skills

SAS programming

R

Clinical trial data analysis

CDISC standards

Oncology-specific endpoints

Education

Graduate/Post-graduate degree in Statistics, Biostatistics, Mathematics, Computer Science, or Pharmacy

Job description

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Title: PRINCIPAL STATISTICAL PROGRAMMER

Location: United States

Remote position

Key Responsibilities:

1. Develop and resolve complex models and procedures using advanced professional knowledge, contributing to managing costs within a unit or sub-unit. This is a fully qualified, experienced professional, journey-level position.
2. Well-versed with CDISC standards and related Therapeutic Area User Guidelines.
3. Proficiency in efficacy analysis.
4. Experience with drug development life cycle, manipulation, analysis, and reporting of clinical trial data.
5. Experience with submissions utilizing define.xml and other submission documents.
6. Handle oncology-specific endpoints, such as tumor response (e.g., RECIST criteria), progression-free survival, overall survival, etc.
7. Work on RECIST, Kaplan-Meier curves, forest plots, Cox proportional hazards models, log-rank tests, biomarker or genomic data if applicable.
8. Lead programming for regulatory submissions (e.g., NDA, BLA, eCTD), integrated summaries (ISS/ISE), and submission-ready deliverables.
9. Create time-to-event datasets for oncology endpoints like PFS, OS, ORR.
10. Experience in immuno-oncology, CAR-T, or combination therapies.
11. Serve as Statistical Programming Lead (SPL) for oncology studies or programs.
12. Work on programming outputs compliant with FDA/EMA requirements.
13. Generate specifications, define.xml, annotated CRFs, and reviewer guides (aSDRG, cSDRG).
14. Standardize and automate across studies or multiple oncology indications.

Education Qualifications:

Graduate/Post-graduate degree or equivalent in Statistics, Biostatistics, Mathematics, Computer Science, or Pharmacy.

Technical Skills:

At least 10 years of SAS programming experience with clinical trial data in the Pharmaceutical & Biotech industry, with a bachelor’s degree or equivalent.

Experience in R, SAS programming, and script/macro development.

Knowledge of relevant therapeutic areas.

Track record of contributions in late-phase clinical trials.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Information Technology

Industries

• Pharmaceutical Manufacturing